DESCRIPTION
id: 37fff5bb-bd06-40a9-9b78-2e83685a6fcf
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is:
(C15H25NO3)2 • C4H6O6
Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.
Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.
HOW SUPPLIED
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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Metoprolol Tartrate Tablets USP, 25 mg – White, circular, film coated tablets with “1” on one side and plain on the other side
Metoprolol Tartrate Tablets USP, 50 mg
– Round, white film coated tablets with “477” debossed on one side and scored on the other side
Blisterpacks of 30 NDC 0615-3552-39
Blisterpacks of 15 NDC 0615-3552-05
Metoprolol Tartrate Tablets USP, 50 mg
– Capsule-shaped, biconvex, white, scored (debossed 166)
Metoprolol Tartrate Tablets USP, 100 mg – Round-shaped, film coated, white colored tablets debossed with “162” on one side and “scored” on the other side.
Metoprolol Tartrate Tablets USP, 100 mg
– Capsule-shaped, biconvex, white, scored (debossed 167)
Blisterpacks of 30 NDC 0615-3553-39
Unit Dose Boxes of 30 NDC 0615-3553-30
Samples, when available, are identified by the word SAMPLE appearing on each bottle.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture.
To report SUSPECTED ADVERSE REACTIONS, contact Caraco Pharmaceutical Laboratories, Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512 5094T88 Iss: 10/14
PRINCIPAL DISPLAY PANEL
id: ef34c9b4-01e5-4fd8-b621-6554b4bd5570
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Metoprolol Tartrate Tablets, USP
50 mg
Rx Only
PRINCIPAL DISPLAY PANEL
id: a8f145f9-ace6-43b6-86be-10a410e05528
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Metoprolol Tartrate Tablets, USP
100 mg
Rx Only